NCT00572767

Brief Summary

The aim of the study is to evaluate the effect of Dextro-amphetamin added to physiotherapy on motor recovery in patients after stroke. The study is a double-blinded placebo-controlled randomised controlled trial. Patients after a first-ever ischemic stroke will receive Dexamphetamine (10mg) twice per week for a duration of five weeks after a baseline phase of two weeks. The outcome measure focuses on motor recovery and will be assessed:

  • one and two weeks before study intervention (baseline phase)
  • five times during the study intervention
  • one week after study intervention (follow-up)
  • once after six and twelve months after start of the study intervention (follow-up).

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_4 stroke

Timeline
Completed

Started Jan 2001

Longer than P75 for phase_4 stroke

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
5.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2007

Completed
Last Updated

December 13, 2007

Status Verified

December 1, 2007

First QC Date

December 12, 2007

Last Update Submit

December 12, 2007

Conditions

Stroke

Keywords

randomised-controlled trialischemic strokemotor recoveryamphetaminemotor recovery of patients after a first-ever ischemic stroke

Outcome Measures

Primary Outcomes (1)

  • Chedoke-McMaster Stroke Assessment (motor impairment measure)

    Over the whole duration of the study (2001 to 2006, ten times for each patient)

Study Arms (2)

1

EXPERIMENTAL
Drug: Dextro-Amphetamin

2

PLACEBO COMPARATOR
Other: Glucose

Interventions

Dextro-AmphetaminDRUG

After a two week baseline phase the patients will receive a dose of 10mg Dexamphetamine on two days per week for five weeks. Within a time frame of one to three hours they should receive physiotherapy focusing on neurodevelopmental (NDT) for one hour.

1
GlucoseOTHER

After a two week baseline phase the patients will receive a dose of 10mg of a placebo (same appearance as the experimental drug) on two days per week for five weeks. Within a time frame of one to three hours they should receive physiotherapy focusing on neurodevelopmental (NDT) for one hour. The treatment of the control group will be the same as for the experimental group except the content of the drug capsule.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients after first-ever ischemic stroke with a clinical relevant paresis of the upper and lower limb (general clinical muscle testing below level four)
  • correlation of clinical symptoms with a brain imaging (CT or MRI)
  • able to communicate with the neurological examiner and understand the aim/matter of the study (with or without aphasia)
  • start of the first oral application of the study drug between the fourteenth and 60th day after stroke onset
  • older than 13 years
  • given written informed consent (or two independent witnesses)

You may not qualify if:

  • intracranial or (chronic) subdural hemorrhages
  • any additional neurological or psychiatric illnesses
  • instable arrythmia
  • not controlled or treated arterial hypertension
  • ensured cardioembolic event
  • anxiolytica, neuroleptica, or alpha-adrenergic antagonists or agonists respectively
  • certain anticonvulsiva or antihypertonica
  • manifest hyperthyreosis
  • dementia or terminal illnesses
  • epilepsy, phaeochromocytoma or glaucoma
  • women known to be pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reha Rheinfelden

Rheinfelden, Canton of Aargau, 4310, Switzerland

Location

Related Publications (1)

  • Schuster C, Maunz G, Lutz K, Kischka U, Sturzenegger R, Ettlin T. Dexamphetamine improves upper extremity outcome during rehabilitation after stroke: a pilot randomized controlled trial. Neurorehabil Neural Repair. 2011 Oct;25(8):749-55. doi: 10.1177/1545968311405674. Epub 2011 Jun 28.

    PMID: 21712481DERIVED

MeSH Terms

Conditions

StrokeIschemic Stroke

Interventions

Glucose

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Thierry M. Ettlin, Prof.

    Reha Rheinfelden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 12, 2007

First Posted

December 13, 2007

Study Start

January 1, 2001

Study Completion

September 1, 2006

Last Updated

December 13, 2007

Record last verified: 2007-12

Locations

CH(1)